February 7th, 2011 Miguel A. Delgado Jr, MD
The Food and Drug Administration (FDA) released what they call a “white paper” on January 26, 2011. This is an advisory statement on Anaplastic Large Cell Lymphoma (ALCL) and a possible link for women with breast implants. ALCL is a non-Hodgkin lymphoma which is a rare cancer that can occur anywhere in the body, and even more rare to be found in the breasts.
The FDA identified 34 unique cases of ALCL in women with breast implants, in scientific literature from January 1, 1997 through May 21, 2010. This is out of about 10 million implanted devices. It is believed that the vast majority of California Bay Area plastic surgeons and plastic surgeons world wide, will never see a single case in a lifetime of practice. Most cases were discovered when women sought medical attention for; capsular contracture, lumps, pain or seromas around their breast implants. The cancer is usually inside the scar tissue of the capsule and is not considered breast cancer.
Recently there have been articles in several publications regarding a possible link between ALCL and breast implants, and there may be more articles to come. While it is important for women to be aware of the situation, there is no need for alarm. The FDA emphasizes this is not breast cancer. The FDA has published a safety communication so that health care providers and the public are informed of the possible association. They are not recommending that women that do not have symptoms or other abnormalities have their implants removed. They have not changed the availability or status of breast implants and have reaffirmed the safety and effectiveness of the devices when used as labeled.
The American Society of Plastic Surgeons (ASPS) and the FDA are establishing a registry to gather more information about ALCL for women with breast implants. Hopefully this information will put San Francisco and Bay area women’s minds at ease, however any questions or concerns, should be directed to their plastic surgeon.